Prostate Cancer Clinical Trial

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Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

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Summary

The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.

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Eligibility Criteria

Inclusion Criteria:

Clinical suspicion for prostate cancer
Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
Scheduled for a initial prostate biopsy

Exclusion Criteria:

Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
History of prostate cancer.
History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
Known hepatitis status (all types) and/or HIV documented in patient's medical record.
Patients with history of concurrent renal/bladder tumors.
Prior MRI used in the decision to biopsy

Study is for people with:

Prostate Cancer

Estimated Enrollment:

120

Study ID:

NCT04720599

Recruitment Status:

Completed

Sponsor:

Exosome Diagnostics, Inc.

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There are 2 Locations for this study

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Chesapeake Urology Research Associates
Baltimore Maryland, 21204, United States
New Jersey Urology
Voorhees New Jersey, 08043, United States
Klinikum der Universität München
München , , Germany

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

120

Study ID:

NCT04720599

Recruitment Status:

Completed

Sponsor:


Exosome Diagnostics, Inc.

How clear is this clinincal trial information?

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